NCT05980910

Brief Summary

Investigation of post-operative recovery among adult patients receiving major abdominal surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

August 21, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 30, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

July 21, 2023

Last Update Submit

August 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • QoR-15 Scores at postoperative day one and day three

    Measure the QoR-15(Quality of Recovery-15) scores on the first day and third day after major abdominal surgery. The QoR-15 score, derived from a 15-item questionnaire using an 11-point numeric rating scale, ranges from 0 to 150, with higher scores indicating better recovery quality.

    72 hours

Study Arms (1)

Major abdominal surgery

Patients undergoing elective major abdominal surgery. The definition of major surgery is the estimated surgery time \>= 2 hours.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Patients receiving major abdominal surgery

You may qualify if:

  • (1) Age 18years and above.
  • (2) Undergoing elective abdominal surgery with an expected surgical time of at least two hours and an expected hospital stay of at least two days.

You may not qualify if:

  • (1) Age under 18 years. (2) Incapacity to give informed consent. (3) Emergency surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hosipital Hsin Chu Branch

Hsinchu, 302, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Related Publications (3)

  • Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020 Jan;75 Suppl 1:e143-e150. doi: 10.1111/anae.14786.

    PMID: 31903564BACKGROUND
  • Johnson A, Rice AN, Titch JF, Gupta DK. Identifying Components Necessary for an Enhanced Recovery After Surgery Pathway for Elective Intracranial Surgery: An Improvement Project Using the Quality of Recovery-15 Score. World Neurosurg. 2019 Oct;130:e423-e430. doi: 10.1016/j.wneu.2019.06.108. Epub 2019 Jul 4.

    PMID: 31279110BACKGROUND
  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 8, 2023

Study Start

August 21, 2023

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

August 30, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations